Quality Engineer
4 weeks ago
Internal Title: Engineer, Quality
Duration: 6-month
Location: Onsite in Scarborough, ME
Responsibilities
- production with resolution of quality issues in accordance with established procedures.
- production on the manufacturing floor, ensuring adherence to procedures and ensure appropriate device history record (DHR) documentation. Supports line clearances, reworks, and inspections as required.
- commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
- for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- and is aware of the quality consequences that may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
- duties as assigned, according to the changing needs of the business.
Qualifications
- Bachelor's degree or equivalent in a related field
- Some previous quality experience
- Experience with batch records, SOPs, structured documentation
- Familiar with quality management systems (agile)
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